Ustekinumab

Alvotech Reports Financial Results for First Quarter of 2024 and Provides a Business Update

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火曜日, 5月 21, 2024
Partnership, CTA, Patient, EBIDTA, Icelandic, Food, Movement, Clinical trial, FDA, EDT, Marketing, Ustekinumab, Food and Drug Administration, Absorption, Denosumab, Research, G&A, Biosimilar, Adalimumab, Webcast, Teva, Teva Pharmaceuticals, Generic drug

Gross margin in Q1 2024 increased to $17 million, by $40 million compared to the same period last year.

Key Points: 
  • Gross margin in Q1 2024 increased to $17 million, by $40 million compared to the same period last year.
  • Alvotech raises topline revenue guidance to $400-$500 million and tightens guidance for bottom line range for 2024 to $100-$150 million.
  • Management will conduct a business update conference call and live webcast on Wednesday May 22, 2024, at 8:00 am ET (12:00 pm GMT).
  • Alvotech will conduct a business update conference call and live webcast on Wednesday, May 22, 2024, at 8:00 am EDT (12:00 pm GMT).

Teva and Alvotech Announce SIMLANDI® (adalimumab-ryvk) Injection Now Available in the U.S.

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火曜日, 5月 21, 2024
Partnership, Patient, Uveitis, Prescription, Food, Rheumatoid arthritis, Johnson & Johnson, FDA, TEVA, Marketing, Ustekinumab, Psoriasis, Ankylosing spondylitis, Senior, Ulcerative colitis, Juvenile idiopathic arthritis, Hidradenitis suppurativa, Adalimumab, Teva, Teva Pharmaceuticals, Generic drug

“We are proud to make SIMLANDI available in the U.S. to patients and providers,” said Thomas Rainey, Senior Vice President, U.S. Market Access at Teva.

Key Points: 
  • “We are proud to make SIMLANDI available in the U.S. to patients and providers,” said Thomas Rainey, Senior Vice President, U.S. Market Access at Teva.
  • “Biosimilars create opportunities for cost savings across the healthcare system, and SIMLANDI’s launch now offers the first citrate-free, high-concentration biosimilar to be designated interchangeable to Humira in the U.S. market.
  • Alvotech handles development and manufacturing, while Teva is responsible for the exclusive commercialization in the U.S., which leverages Teva’s experience and extensive sales and marketing infrastructure.
  • Humira is a registered trademark of AbbVie Biotechnology Ltd. Stelara is a registered trademark of Johnson & Johnson.

Teva and Alvotech Announce SIMLANDI® (adalimumab-ryvk) Injection Now Available in the U.S.

Retrieved on: 
火曜日, 5月 21, 2024
Biotechnology, FDA, Pharmaceutical, Health, Partnership, Patient, Uveitis, Prescription, Food, Rheumatoid arthritis, Johnson & Johnson, Medication, TEVA, Marketing, Ustekinumab, Psoriasis, Ankylosing spondylitis, Senior, Ulcerative colitis, Juvenile idiopathic arthritis, Hidradenitis suppurativa, Adalimumab, Multimedia, Teva, Teva Pharmaceuticals

View the full release here: https://www.businesswire.com/news/home/20240520679234/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240520679234/en/
    “We are proud to make SIMLANDI available in the U.S. to patients and providers,” said Thomas Rainey, Senior Vice President, U.S. Market Access at Teva.
  • “Biosimilars create opportunities for cost savings across the healthcare system, and SIMLANDI’s launch now offers the first citrate-free, high-concentration biosimilar to be designated interchangeable to Humira in the U.S. market.
  • Alvotech handles development and manufacturing, while Teva is responsible for the exclusive commercialization in the U.S., which leverages Teva’s experience and extensive sales and marketing infrastructure.
  • Humira is a registered trademark of AbbVie Biotechnology Ltd.
    Stelara is a registered trademark of Johnson & Johnson.

High-Cost Drugs Fuel ‘Unsustainable’ Surge in Prescription Spend for Employers

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木曜日, 5月 16, 2024
Technology, Insurance, Human Resources, Professional Services, Software, Health, Data Analytics, Pharmaceutical, Data Management, Spend, Risankizumab, Prescription, Diabetes medication, Inflammation, Ustekinumab, Growth, Adalimumab, Autoimmunity, C-peptide, Secukinumab, Pharmaceutical industry

Nomi Health’s Trends in Spend research also found:

Key Points: 
  • Nomi Health’s Trends in Spend research also found:
    Prescription spending increased by an average of 10% yearly from 2020 to 2023.
  • Biologics used to treat autoimmune and inflammatory disorders are the most expensive individual drugs contributing to prescription spend.
  • These specialty drugs can average more than $35,000 per member per year and are consistently among the most expensive drugs for employers.
  • Antidiabetic medications as a group now have a higher price tag than the costliest individual drugs and are the leading drug group contributing to employers’ prescription spend.

EQS-News: Formycon reports on successful operating business and financial figures for the first quarter of 2024

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金曜日, 5月 10, 2024
FDA, Internet, CFO, Investment, PIN, Fresenius (company), Food, Biosimilar, Pembrolizumab, Depreciation, Johnson & Johnson, Teva, Partnership, Eye, Tax, Ustekinumab, Gulf Cooperation Council, MENA, GCC, Scott Richter, Patient, Acquisition, EMA, Marketing, Novartis, European Medicines Agency, Pharmaceutical industry

Press Release // May 8, 2024

Key Points: 
  • Press Release // May 8, 2024
    Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) today published figures for the first quarter of financial year 2024.
  • Formycon confirms the financial guidance issued in April for the 2024 financial year.
  • FYB201 is expected to be marketed under the trade name Ravegza® [2] in Saudi Arabia from the second quarter of 2024.
  • The Management Board of Formycon AG will discuss the development of the company and the key financial figures for the first quarter of the financial year 2024 in a conference call.

Rani Therapeutics Reports First Quarter 2024 Financial Results; Provides Corporate Update

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月曜日, 5月 6, 2024
Biosimilar, Research, Celltrion, Teriparatide, Osteoporosis, Human, Ustekinumab, HC, Patient, Physician, Workforce, SAN, Injection, Pharmaceutical industry

SAN JOSE, Calif., May 06, 2024 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today reported financial results for the quarter ended March 31, 2024 and provided a corporate update.

Key Points: 
  • SAN JOSE, Calif., May 06, 2024 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today reported financial results for the quarter ended March 31, 2024 and provided a corporate update.
  • “We are pleased with the progress we have made in the first quarter having announced positive topline results from our Phase 1 study for RT-111.
  • In February 2024, Rani announced RT-111 achieved high bioavailability and was well-tolerated, with no serious adverse events in humans in a Phase 1 study.
  • First Quarter 2024 Financial Results:
    Cash, cash equivalents and marketable securities as of March 31, 2024 totaled $39.6 million, compared to $48.5 million for the year ended December 31, 2023.

EQS-News: Formycon reports audited annual results for the financial year 2023 – Looking back on a successful operative year and exceeded guidance

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金曜日, 5月 3, 2024
FDA, CFO, Patient, Bank statement, Internet, Web browser, Investment, Zoom, Fresenius (company), Biosimilar, Pembrolizumab, Depreciation, Annual report, Partnership, WACC, Ustekinumab, Development, Tax, EMA, Ranibizumab, Economic development, Marketing, ID, Telephone, COVID-19, Growth, Cryptocurrency

In 2023, we reached all the operational milestones we had set and therewith laid the foundations for a successful and profitable future.

Key Points: 
  • In 2023, we reached all the operational milestones we had set and therewith laid the foundations for a successful and profitable future.
  • Enno Spillner, CFO of Formycon AG, adds: “We have presented excellent financial figures for 2023 and reached or exceeded the guidance.
  • In future reporting, Formycon will replace the previous financial performance indicator "consolidated net result" with the new indicator "adjusted Group EBITDA".
  • The complete Annual Report 2023 can be found on the Formycon website at Financial Reports.

Samsung Bioepis Gains European Commission Approval For PYZCHIVA™, a Biosimilar to Stelara (Ustekinumab)

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月曜日, 4月 22, 2024
Gastroenterology, Safety, Pharmacokinetics, Rheumatology, European Commission, Biosimilar, Partnership, Ustekinumab, Patient, Regulatory affairs, Psoriasis, Civil service commission, Novartis, Dermatology

INCHEON, Korea, April 22, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced that the European Commission (EC) has granted marketing authorization for PYZCHIVA™, a biosimilar to Stelara1,2 (ustekinumab), paving the way for expanding its immunology portfolio.

Key Points: 
  • INCHEON, Korea, April 22, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced that the European Commission (EC) has granted marketing authorization for PYZCHIVA™, a biosimilar to Stelara1,2 (ustekinumab), paving the way for expanding its immunology portfolio.
  • PYZCHIVA is approved for the treatment of certain autoimmune disorders in gastroenterology, dermatology and rheumatology.
  • “We are proud to have our fourth immunology biosimilar approved in Europe,” said Byoungin Jung, Vice President and Regulatory Affairs Team Leader, at Samsung Bioepis.
  • PYZCHIVA will be commercialized by Sandoz under Samsung Bioepis and Sandoz’s partnership.

EQS-News: Formycon and Fresenius Kabi reach settlement agreement for ustekinumab biosimilar candidate FYB202 in Europe and Canada

Retrieved on: 
水曜日, 4月 10, 2024
Ulcerative colitis, Psoriasis, Ustekinumab, Patient, EMA, Interleukin, European Medicines Agency, Fresenius (company), Cytokine, Johnson & Johnson, FDA, Food, Pharmaceutical industry

Press release // March 18, 2024

Key Points: 
  • Press release // March 18, 2024
    Munich, Germany – Formycon AG (FSE: FYB) and its commercialization partner Fresenius Kabi today announced the signing of a settlement agreement with Johnson & Johnson concerning the commercialization of FYB202, a biosimilar to Stelara®1 (ustekinumab), in Europe and Canada.
  • It was agreed to keep the terms of the agreement confidential.
  • Our aim is to make a significant difference in patients' lives by providing them with reliable, high-quality, and affordable treatment options.
  • In February 2023, Formycon and Fresenius Kabi had entered into a global license agreement for the ustekinumab biosimilar candidate FYB202, under which FYB202 will be marketed by Fresenius Kabi in key global markets following successful approval.

Samsung Bioepis Presents Two Abstracts for Its Immunology Portfolio at the 2024 American Academy of Dermatology (AAD) Annual Meeting

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土曜日, 3月 9, 2024
EMA, Week, Psoriasis, Committee, SB5, Political moderate, Ustekinumab, Organon, FDA, Food, Samsung, BLA, Trial of the century, AAD, Safety, CHMP, Pharmacokinetics, Abstract, Biologics license application, American Academy, Novartis, Interchangeability

“We are excited to present new clinical data for our immunology portfolio at AAD Annual Meeting.

Key Points: 
  • “We are excited to present new clinical data for our immunology portfolio at AAD Annual Meeting.
  • The high-concentration (40 mg/0.4 mL) formulation of prefilled syringe and prefilled autoinjector of HADLIMA was approved in August 2022.
  • The study showed that efficacy, safety, and immunogenicity between the three arms were comparable up to Week 52.
  • Details of the Samsung Bioepis’ abstracts are as follows:
    Clinical Similarity of SB17 (Proposed Ustekinumab Biosimilar) to Reference Ustekinumab in Patients with Moderate to Severe Plaque Psoriasis: Randomized, Double-blind, Phase III, 52-Week Results